Acupuncture in Postoperative Pain Control for Minimal Invasive Thoracoscopic Surgery Patients

December 8, 2016 updated by: China Medical University Hospital

Investigate the Efficacy of Acupuncture in Postoperative Pain Control for Minimal Invasive Thoracoscopic Surgery Patients

Minimal invasive thoracoscopic surgery has been used widely for common thoracic diseases in recent years. Patients who received thoracoscopic surgery recovered much quickly and returned to their daily life sooner because of small operation wound and less invasion. However, operative pain was still an important factor, which might contribute to several post-operative complications.

In daily practice, patients received oral/intravenous form non-steroidal anti-inflammatory drugs and opioid agents, or patient-controlled analgesia for post operative pain control. However, some side effects were observed occasionally.

The role of acupuncture in post-operative pain control was frequently discussed in recent research. The main mechanisms of acupuncture in pain control were (1) to stimulate the release of endogenous opioid and (2) to block TRPV1 receptor.

The randomized controlled trial arranged by Gary Deng and his colleagues in 2008, was the first clinical trial investigated the role of acupuncture in post-operative pain control for traditional thoracotomy patients. However, there was no further research about the role of acupuncture applied to minimal invasive thoracoscopic surgery.

Thus, the aim of this randomized controlled trial was to investigate the role of acupuncture in post-operative pain control for minimal invasive thoracoscopic surgery patients. In order to deliver a safe and effective way in pain control, and to save medical cost and promote quality of patient care.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taichung, Taiwan, 404
        • Recruiting
        • Division of thoracic surgery, China medical university hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age more than 20-year-old
  • Both male and female patients
  • Nationality: Republic of China (R.O.C., Taiwan)
  • Who received thoracoscopic surgery for benign lung tumor/disease, metastatic lung tumor, primary lung cancer, mediastinal tumor

Exclusion Criteria:

  • Abnormal function of coagulation
  • Platelet count less than 20 x 10^3/mm^3
  • International normalized ratio (INR) more than 2.5
  • Severe comorbidity, for example central vascular, cardiovascular disease, liver/renal failure
  • Who would not cooperate in access, or express appropriately

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Sham Comparator: Sham Acupuncture
After recruitment, participants will be randomized to receive acupuncture or sham acupuncture treatment. In the sham acupuncture group, participants will receive sham acupuncture.
Procedure: Sham Acupuncture

Procedure:

Sham Acupuncture(ipisilateral side, 0.3cun, No needle sensation (de qi) was elicited) Sham acupuncture will be applied by inserting acupuncture needle into acupoints(1cm away from the true acupoint):upper limb: Waiguan TE5; lower limb: Zusanli ST36.

All procedures were carried out to a depth of 0.5 cm with disposable needles measuring 0.16 mm in diameter (40-gauge) and 12.7 mm in length (Yu Kuang, Taipei, Taiwan).

Acupuncture treatment will consist of one session per day and consecutive three days after thoracoscopic surgery.
Experimental: Acupuncture
After recruitment, participants will be randomized to receive acupuncture or sham acupuncture treatment. In the acupuncture group, participants will receive acupuncture.
Procedure: Acupuncture

Procedure:

Acupuncture(ipisilateral side, the needling depth decided by whether patients feel De qi, neutral supplementation and draining) Acupuncture will be applied by inserting acupuncture needle into acupoints: Zhigou TE6, Shousanli LI10, Hegu LI4, Neiguan PC6, Houxi SI3; lower limb: Biguan ST31, Fushe SP13, Zulinqi GB41; axillary area(Remove Needles right away after De qi): Yuanye GB22, Jiquan HT1; local area(Remove Needles right away after De qi): ashi point close to the pain area.

The other needles will be left for 20 minutes and then removed. All procedures were carried out with disposable needles measuring 0.25 mm in diameter (32-gauge) and 44 mm in length (Yu Kuang, Taipei, Taiwan).

Acupuncture treatment will consist of one session per day and consecutive three days after thoracoscopic surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline pain scale at post operative day 2, after intervention
Time Frame: measure at post-operative day 1, 9AM, before intervention; and post-operative day 2, 5PM, after intervention
  1. Pain, as assessed by Numeric Rating Scale, NRS
  2. Measure at post-operative day 1, 9AM, before intervention; and post-operative day 2, 5PM, after intervention
  3. accompanied with rest, deep breath, cough and change posture by left and right decubitus
measure at post-operative day 1, 9AM, before intervention; and post-operative day 2, 5PM, after intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Opioid dosage
Time Frame: injection times of morphine or ketorolac would be recorded during whole admission, an average of 7 days
  1. Routine pain control was given with oral form acetaminophen (500mg, at every 9AM, 1PM, 5PM and 9PM)
  2. Additional Morphine was given for intolerable pain (0.05mg/kg, intramuscular injection)
  3. Additional Ketorolac was given for intolerable pain after morphine used (15mg, intramuscular injection)
  4. Avoid patient controlled analgesia (PCA) using
injection times of morphine or ketorolac would be recorded during whole admission, an average of 7 days
Von Frey hair Test
Time Frame: measure at post-operative day 1, 9AM, before intervention; and post-operative day 2, 5PM, after intervention
  1. Pain, as assessed by von Frey hair Test at each wound sites
  2. Measure at post-operative day 1, 9AM, before intervention; and post-operative day 2, 5PM, after intervention
measure at post-operative day 1, 9AM, before intervention; and post-operative day 2, 5PM, after intervention
Vital signs
Time Frame: measure during whole admission, an average of 7 days
  1. Measure at every 9AM, 1PM, 5PM and 9PM
  2. Including blood pressure, heart rate, breath rate, body temperature
measure during whole admission, an average of 7 days
Questionnaire
Time Frame: measure before discharge, an average at post operative day 5
1. Including quality control of acupuncture, discomfort and satisfaction during whole admission, an average of 7 days
measure before discharge, an average at post operative day 5

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

China Medical University Hospital

Investigators

  • Principal Investigator: Ting Yu Lu, MD, Division of thoracic surgery, China medical university hospital, Taiwan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2016

Primary Completion (Anticipated)

June 1, 2017

Study Completion (Anticipated)

October 1, 2017

Study Registration Dates

First Submitted

November 3, 2016

First Submitted That Met QC Criteria

November 5, 2016

First Posted (Estimate)

November 9, 2016

Study Record Updates

Last Update Posted (Estimate)

December 12, 2016

Last Update Submitted That Met QC Criteria

December 8, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CMUH105-REC2-097

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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